Hope For LLY’s Alzheimer’s Drug Remains Alive; Stock Will Reflect Optimism

Eli Lilly & Co. (NYSE:LLY) announced this morning that its potential treatment to slow the onset of Alzheimer’s Disease, solanezumab, showed favorable effects in its Phase III clinical program. Shares of LLY were off initially in pre-market trading on the headline that the drug missed its primary endpoint for improving cognition and function in each of its two Phase III trials in patients with mild to moderate Alzheimer’s disease. However, when the company pooled the data, results showed that there actually was a statistically significant improvement in the reduction of “cognitive decline” across both trials. While this was a secondary endpoint, combining the data from both trials was a “pre-specified analysis” meaning that it is a more legitimate cut of the data. Lilly had been pro-active in guiding investors that it would not reveal data from each trial separately, but that the company would only release results when the combined data became available. In addition, a pre-specified subgroup analysis of the pooled data showed that mild Alzheimer’s patients experienced a statistically significant slowing of cognitive decline, while moderate Alzheimer’s disease patients did not. LLy stated on a conference call this morning that the reason the individual trials did not show the significance was that the number of mild patients in each trial was too small to drive the results, yet pooled data sufficiently increased presence. These results indicate that LLY will gear any future trials to enroll mild patients to verify this effect, and that if the effect is validated, the drug could be used in earlier-stage patients. (more…)